Prochlorperazine
MedicationPhenothiazine antiemetic
Research strength: 4 / 5
RCOG includes prochlorperazine among phenothiazine nausea medicines and reports no increased birth defects or other pregnancy problems across reviews of several anti-nausea medicines. NICE also says available evidence does not suggest more birth defects. The DailyMed injection label differs: it says pregnancy safety is not established and limits use to severe nausea and vomiting when a clinician judges benefits outweigh possible harms. A 2026 US claims study screened 18,366 first-trimester prochlorperazine exposures and found no statistical birth-defect alerts, but this screen cannot rule out risk. DailyMed's boxed warning states, "Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death"; this injection is not approved to treat dementia-related psychosis. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- DailyMed: Prochlorperazine edisylate injection (Sagent)Drug company label
- RCOG Green-top Guideline 69: Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum
- NICE NG201 Table 1: Pharmacological treatments for nausea and vomiting in pregnancy
- Straub et al., BMJ Mental Health 2026: Congenital malformation risk following prenatal antipsychotic exposureUS government
Research strength: 4 / 5
RCOG includes prochlorperazine among phenothiazine nausea medicines and reports no increased birth defects or other pregnancy problems across reviews of several anti-nausea medicines. NICE also says available evidence does not suggest more birth defects. The DailyMed injection label differs: it says pregnancy safety is not established and limits use to severe nausea and vomiting when a clinician judges benefits outweigh possible harms. A 2026 US claims study found no statistical birth-defect alerts after first-trimester prochlorperazine exposure, but it did not study second-trimester exposure. DailyMed's boxed warning states, "Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death"; this injection is not approved to treat dementia-related psychosis. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- DailyMed: Prochlorperazine edisylate injection (Sagent)Drug company label
- RCOG Green-top Guideline 69: Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum
- NICE NG201 Table 1: Pharmacological treatments for nausea and vomiting in pregnancy
- Straub et al., BMJ Mental Health 2026: Congenital malformation risk following prenatal antipsychotic exposureUS government
Research strength: 3 / 5
DailyMed warns that babies exposed to antipsychotic medicines in the third trimester may show movement or withdrawal symptoms, such as tremor, stiff muscles, sleepiness, breathing problems or feeding difficulties. NICE also lists restlessness, trembling, muscle stiffness or spasms, and withdrawal symptoms after third-trimester use. A small 1992 study of 12 women taking antipsychotic and anti-anxiety medicines late in pregnancy reported tremor, increased muscle tone and immature movement in newborns, especially after phenothiazines, but did not estimate prochlorperazine-specific effects. DailyMed says pregnancy use should occur only if potential benefits justify fetal risk and limits use to severe nausea and vomiting. DailyMed's boxed warning states, "Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death"; this injection is not approved to treat dementia-related psychosis. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- DailyMed: Prochlorperazine edisylate injection (Sagent)Drug company label
- NICE NG201 Table 1: Pharmacological treatments for nausea and vomiting in pregnancy
- Auerbach et al., Neurotoxicology and Teratology 1992: Maternal psychotropic medication and neonatal behaviorUS government
Prochlorperazine — Breastfeeding
Research strength: 3 / 5
According to LactMed, occasional short-term prochlorperazine appears to pose little risk based on related phenothiazines, but no measurements of prochlorperazine in milk or infant outcomes were found. NHS SPS says no published breastfeeding evidence is available and advises caution for short-term use with infant monitoring. DailyMed says phenothiazines are excreted in breast milk and advises caution. LactMed reports unexpected milk production, called galactorrhea, and says prolactin levels may not affect established breastfeeding. DailyMed's boxed warning states, "Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death"; this injection is not approved to treat dementia-related psychosis. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- LactMed: ProchlorperazineUS government
- NHS Specialist Pharmacy Service: Treating nausea during breastfeedingUK government
- DailyMed: Prochlorperazine edisylate injection (Sagent)Drug company label
Pregnancy
RCOG's 2024 Green-top Guideline 69 groups prochlorperazine with phenothiazines and reports that evidence reviews and birth-registry data across several antiemetics found no increased teratogenesis or other adverse pregnancy outcomes; this is class and group evidence, not a prochlorperazine-specific effect estimate. NICE's 2021 table says available evidence does not suggest increased birth defects, but notes there is no randomized-trial evidence for prochlorperazine in pregnancy sickness and records manufacturer restrictions. In Straub et al. (2026), a US claims cohort included more than 4.2 million mother-child dyads and 18,366 first-trimester prochlorperazine exposures; no statistical alerts with p<0.1 were detected for the drug. The authors describe the screening approach as hypothesis-generating, not confirmatory of safety or risk, and it examined malformations rather than miscarriage or later-trimester exposure. Quinn et al. (2026) pooled 12 antipsychotic studies with over 10 million pregnancies: the class-level congenital-malformation estimate was OR 1.27 (95% CI 0.996-1.624) and the preterm-birth estimate was OR 1.35 (95% CI 1.13-1.62), with moderate to high heterogeneity. The meta-analysis did not estimate prochlorperazine-specific risks. One included study reported separate anti-nausea treatment results for dixyrazine/prochlorperazine and other antipsychotics; the latter group entered the main analysis, while a pooled estimate for the anti-nausea group was examined in a sensitivity analysis. No prochlorperazine-specific miscarriage estimate was identified in the reviewed sources.
Breastfeeding
LactMed (last revised 15 July 2024) says occasional short-term use appears to pose little risk based on minimal excretion of other phenothiazines, but reports no published maternal milk levels or infant effects for prochlorperazine. NHS SPS (26 March 2024) also reports no published evidence of use during breastfeeding and advises caution for occasional short-term use with infant monitoring. DailyMed's injection label says phenothiazines are excreted in human milk and advises caution, without providing prochlorperazine milk-level or infant-outcome data. LactMed's low-risk statement is extrapolated from related medicines rather than direct measurements or infant outcome studies for this drug.
Prochlorperazine is a phenothiazine antiemetic used to treat nausea and vomiting.
What was tested
The 2026 US cohort evaluated first-trimester dispensing and congenital-malformation codes in liveborn children; it did not estimate miscarriage or later-trimester outcomes, and a filled prescription does not confirm ingestion. The 2026 meta-analysis pooled antipsychotic-class outcomes and could not estimate an individual prochlorperazine effect; many included studies excluded the medicine, and one grouped it with dixyrazine. Auerbach et al. assessed newborn behavior at 3 and 14 days after late-pregnancy mixed antipsychotic and anti-anxiety medication exposure; it did not identify prochlorperazine as the specific exposure. For breastfeeding, LactMed and NHS SPS found no published prochlorperazine milk-level or infant-outcome evidence.
Pregnancy use and birth-defect evidence
- Source A says
- DailyMed says pregnancy safety has not been established and the injection is not recommended except for severe, intractable nausea and vomiting when a clinician judges intervention necessary and potential benefits outweigh possible hazards. (DailyMed: Prochlorperazine edisylate injection (Sagent))
- Source B says
- RCOG includes prochlorperazine among phenothiazines supported by evidence reviews and birth-registry data that found no increased teratogenesis or other adverse pregnancy outcomes; NICE calls it established practice and says available evidence does not suggest increased birth defects. (RCOG Green-top Guideline 69: Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum, NICE NG201 Table 1: Pharmacological treatments for nausea and vomiting in pregnancy)
- Why they differ
- The injection label emphasizes that pregnancy safety has not been established and limits use to severe symptoms. RCOG and NICE synthesize broader antiemetic evidence and established clinical practice. The label precaution is not evidence that prochlorperazine causes birth defects, while the guideline evidence is not a drug-specific guarantee.
- Other sources
- A 2026 US first-trimester screen included 18,366 prochlorperazine-exposed pregnancies and detected no statistical malformation alerts for this medicine; the authors say the hypothesis-generating method does not confirm absence of risk. (Straub et al., BMJ Mental Health 2026: Congenital malformation risk following prenatal antipsychotic exposure)
- What the evidence shows overall
- Under R1 and R2, the evidence supports compatible ratings for T1 and T2 with the label restriction and disagreement disclosed. The first-trimester cohort adds drug-specific screening information but does not resolve second-trimester risk or rule out an effect. Avoid is not supported because no confirmed prochlorperazine-specific pregnancy risk signal was identified.
Interpretation of limited breastfeeding evidence
- Source A says
- LactMed says occasional short-term use appears to pose little risk based on minimal excretion of related phenothiazines, while reporting no published prochlorperazine milk levels or infant effects. (LactMed: Prochlorperazine)
- Source B says
- DailyMed says phenothiazines are excreted in human milk and advises caution. NHS SPS advises caution for occasional short-term use with infant monitoring and reports no published prochlorperazine breastfeeding evidence. (DailyMed: Prochlorperazine edisylate injection (Sagent), NHS Specialist Pharmacy Service: Treating nausea during breastfeeding)
- Why they differ
- LactMed's reassurance is based on pharmacologic extrapolation from related phenothiazines, while the label and NHS SPS emphasize milk exposure or precautionary monitoring in the absence of direct data.
- What the evidence shows overall
- There are no direct human milk-level or infant-outcome data for prochlorperazine in the reviewed sources. Keep the rating at guidance, describe LactMed's statement as extrapolation, and retain the label and NHS SPS caution.
- RCOG includes phenothiazines such as prochlorperazine among antiemetics that may be offered when clinically needed, with counseling about benefits and risks. (RCOG Green-top Guideline 69)
- NHS SPS says occasional, short-term prochlorperazine may be used with caution during breastfeeding and recommends infant monitoring. (NHS Specialist Pharmacy Service)
General research, not specific to pregnancy.
DailyMed's boxed warning covers increased mortality in elderly patients with dementia-related psychosis; the injection is not approved to treat that condition. The label also describes prolactin-related effects, including galactorrhea.
- The boxed warning states: "Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death." DailyMed says this injection is not approved for dementia-related psychosis. (DailyMed: Prochlorperazine edisylate injection (Sagent))
- DailyMed says antipsychotic drugs elevate prolactin and that disturbances including galactorrhea have been reported; it says the clinical significance of elevated serum prolactin is unknown for most patients. (DailyMed: Prochlorperazine edisylate injection (Sagent))
- LactMed reports galactorrhea with prochlorperazine and says prolactin levels in a mother with established lactation may not affect her ability to breastfeed. (LactMed: Prochlorperazine)
- DailyMed: Prochlorperazine edisylate injection (Sagent)Drug company labelTertiaryPage dated 2026-09-22
- LactMed: ProchlorperazineUS governmentSecondaryPage dated 2024-07-15
- RCOG Green-top Guideline 69: Management of Nausea and Vomiting in Pregnancy and Hyperemesis GravidarumSecondaryPage dated 2024-02-04Independent check
- NICE NG201 Table 1: Pharmacological treatments for nausea and vomiting in pregnancySecondaryIndependent check
- Straub et al., BMJ Mental Health 2026: Congenital malformation risk following prenatal antipsychotic exposureUS governmentPrimaryPage dated 2026-04-08Independent check
- Quinn et al., Archives of Women's Mental Health 2026: Antipsychotic drug use during pregnancy and neonatal outcomesUS governmentPrimaryPage dated 2026-01-08Independent check
- Auerbach et al., Neurotoxicology and Teratology 1992: Maternal psychotropic medication and neonatal behaviorUS governmentPrimaryIndependent check
- NHS Specialist Pharmacy Service: Treating nausea during breastfeedingUK governmentSecondaryPage dated 2024-03-26Independent check
Last reviewed 2026-10-16
Independent check 2026-10-16
Not yet clinician-reviewed
Ask your provider about your situation.
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